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Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer (TDICC)

Primary Purpose

Small Cell Lung Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Irinotecan

Cisplatin

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma focused on measuring Irinotecan; Cisplatin; Small-cell lung cancer; UGT1A1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologic or cytologic diagnosis of small-cell lung cancer
Extensive-stage disease, defined as disease extending beyond one hemithorax involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or pleural effusion.
Males or females between 18 to 75 years
No prior chemotherapy, if the surgery or radiotherapy has been administered, the interval is at least above four weeks.
Performance status of 0-2 on the ECOG criteria. Expected survival is above three months.
At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNL x 1.5), and renal (creatinine =< UNL) function
The gene type of UGT1A1 *28 is 6/6 and 6/7.
If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.

Exclusion Criteria:

Non small cell lung cancer and carcinoid
Medically uncontrolled severe diarrhea in recent three weeks.
Inability to comply with protocol or study procedures.
Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Pregnant or breast-feeding.
Enrollment in other study within 30 days
Brain metastasis with symptoms

Sites / Locations

Chongqing Cancer HospitalRecruiting
Xinan Hospital, Third Military Medical UniversityRecruiting
Xinqiao Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Irinotecan 90mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.

Irinotecan 65mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

overall survival

Tumor response rate

the ratio between the number of responders and number of patients assessable for tumor response

Toxicity

Quality of life

Full Information

NCT ID

NCT01977235

First Posted

October 15, 2013

Last Updated

March 31, 2016

Sponsor

Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01977235

Brief Title

Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

Acronym

TDICC

Official Title

An Open, Randomized, Parallel Control, Multiple-center Phase II Trial of Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Military Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene *28 (6/6 and 6/7) and *6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene *28 (7/7) and *6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out the efficacy and side effect between two different dosages of irinotecan combined with cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene *28 (6/6 and 6/7)and *6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene *28 (7/7) and *6 (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the efficacy without increasing the side effect in the patients with UGT1A1 gene *28 (6/6 and 6/7)*6 (G/G and G/A).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Carcinoma

Keywords

Irinotecan; Cisplatin; Small-cell lung cancer; UGT1A1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Irinotecan 90mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

Irinotecan 65mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Primary Outcome Measure Information:

Title

progression-free survival

Time Frame

The first day of treatment to the date that disease progression is reported; assessed up to 3 years

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

the first day of treatment to death or last survival confirm date; assesed up to 3 years

Title

Tumor response rate

Description

the ratio between the number of responders and number of patients assessable for tumor response

Time Frame

Up to 3 years

Title

Toxicity

Time Frame

the first date of treatment to 30 days after the last dose of study drug

Title

Quality of life

Time Frame

the day before every cycle of chemotherapy; 30 days after the last dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologic or cytologic diagnosis of small-cell lung cancer Extensive-stage disease, defined as disease extending beyond one hemithorax involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or pleural effusion. Males or females between 18 to 75 years No prior chemotherapy, if the surgery or radiotherapy has been administered, the interval is at least above four weeks. Performance status of 0-2 on the ECOG criteria. Expected survival is above three months. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000). Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative. Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNL x 1.5), and renal (creatinine =< UNL) function The gene type of UGT1A1 *28 is 6/6 and 6/7. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment. No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole. Exclusion Criteria: Non small cell lung cancer and carcinoid Medically uncontrolled severe diarrhea in recent three weeks. Inability to comply with protocol or study procedures. Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. Pregnant or breast-feeding. Enrollment in other study within 30 days Brain metastasis with symptoms

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xueqin Yang, M.D.

Phone

+86-023-68757158

yangxueqin@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xueqin Yang, M.D.

Organizational Affiliation

Daping Hospital, Third Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chongqing Cancer Hospital

City

Chongqing

State/Province

Chongqing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qiying Li, M.D.

Phone

13637808684

First Name & Middle Initial & Last Name & Degree

Qiying Li, M.D.

First Name & Middle Initial & Last Name & Degree

Dairong Li

Facility Name

Xinan Hospital, Third Military Medical University

City

Chongqing

State/Province

Chongqing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Xiong, M.D.

Phone

+86-13512345225

First Name & Middle Initial & Last Name & Degree

Wei Xiong

Facility Name

Xinqiao Hospital, Third Military Medical University

City

Chongqing

State/Province

Chongqing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bo Zhu, M.D.

Phone

+86-15923366951

First Name & Middle Initial & Last Name & Degree

Bo Zhu, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

16648503

Citation

Hanna N, Bunn PA Jr, Langer C, Einhorn L, Guthrie T Jr, Beck T, Ansari R, Ellis P, Byrne M, Morrison M, Hariharan S, Wang B, Sandler A. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol. 2006 May 1;24(13):2038-43. doi: 10.1200/JCO.2005.04.8595.

Results Reference

background

PubMed Identifier

23686699

Citation

Gao J, Zhou J, Li Y, Lu M, Jia R, Shen L. UGT1A1 6/28 polymorphisms could predict irinotecan-induced severe neutropenia not diarrhea in Chinese colorectal cancer patients. Med Oncol. 2013;30(3):604. doi: 10.1007/s12032-013-0604-x. Epub 2013 May 18.

Results Reference

background

PubMed Identifier

22983686

Citation

Zhang X, Meng X, Wang Y, Yan W, Yang J. Comprehensive analysis of UGT1A1 genetic polymorphisms in Chinese Tibetan and Han populations. Biochem Genet. 2012 Dec;50(11-12):967-77. doi: 10.1007/s10528-012-9536-y. Epub 2012 Sep 16.

Results Reference

background

PubMed Identifier

11784874

Citation

Noda K, Nishiwaki Y, Kawahara M, Negoro S, Sugiura T, Yokoyama A, Fukuoka M, Mori K, Watanabe K, Tamura T, Yamamoto S, Saijo N; Japan Clinical Oncology Group. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):85-91. doi: 10.1056/NEJMoa003034.

Results Reference

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Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

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